Brazilian Version of an Intervention to Support Healthy Lifestyle Adoption Post-stroke - iVIDAVC

It will be determined by the ratio between the total number of eligible individuals (EI) and the total number of screened individuals (SI) (measure=EI/IS), and by the ratio between the total number of eligible individuals (EI) and the total number of recruited individuals (RI) (measure=EI/RI).

It will be determined by the ratio between the total number of individuals who completed the proposed intervention program and the total number of individuals who started the proposed intervention program.

It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.

It will be determined the ratio between the total number of individuals who remained in the same group to which they were initially allocated until follow-up and the total number of individuals who were allocated.

It will be assessed by comparing the content delivered during each session with the content specified in the intervention protocol. The proportion of planned session components delivered will be recorded.

It will be determined by the number and reasons of adverse events (e.g. pain, falls, hospitalization, and death) identified during the period of intervention and follow-up of the individual.

Acceptability of the intervention will be assessed using participant feedback on five-point Likert scales, with the following response options: "totally agree", "partially agree", "neither agree nor disagree", "partially disagree", and "totally disagree". Participants will rate the following items: (1) overall satisfaction with the activities conducted by the health professional during the intervention; (2) helpfulness of the educational materials in supporting the adoption of a healthy lifestyle; (3) satisfaction with the overall time required for the intervention, considering the total number of weekly sessions; (4) satisfaction with the duration of the intervention sessions, including 1 hour for the educational session, 1 hour for the individual session, and 2 hours for group sessions; and (5) overall satisfaction with the intervention. These scales were informed by previous studies.

It will be determined by the following question: "Comparing how it was before you performed the intervention and now, do you consider your lifestyle to be healthier: strongly agree, partially agree, neither agree nor disagree, partially disagree, strongly disagree".

It will be assessed using participant feedback to the following question: "Compared to before participating in the intervention, how would you rate your overall health now?". Participants will rate their perceived change in overall health using five response options: "much better", "somewhat better", "about the same", "somewhat worse", and "much worse". This assessment will capture participants' perception of changes in their overall health following participation in the iVIDAVC intervention.

It will be assessed using participant feedback to the following question: "Compared to before participating in the intervention, how would you rate your lifestyle now?". Participants will rate their perceived change in lifestyle using five response options: "much better", "somewhat better", "about the same", "somewhat worse", and "much worse". This assessment will capture participants' perception of changes in their lifestyle following participation in the iVIDAVC intervention.

It will be determined by the percentage of clinical outcomes successfully measured (i.e., the ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured).

The feasibility of blinding the outcome assessor will be determined by the number and percentage of participants for whom the blinded outcome assessor correctly guesses the treatment allocation.

Costs associated with staff training (e.g., materials and transportation), recruitment (e.g., telephone calls and printing of folders), screening, assessment of inclusion and exclusion criteria, outcome assessment (e.g., transportation costs for participants and staff, printing of assessment materials, and material costs), and intervention delivery (e.g., telephone calls) will be recorded.

Goal Attainment Scaling (GAS). The GAS T-score will be used to assess the degree of attainment of the participant's behavioral change goals. Changes in the GAS T-score will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up to determine whether goal attainment is maintained, increased, or decreased over time.

Knowledge about stroke will be assessed using six questions addressing participants' knowledge of stroke, its signs and symptoms, risk factors for stroke occurrence, the possibility of experiencing a recurrent stroke, the role of healthy lifestyle behaviors in reducing the risk of recurrent stroke, and how to establish goals to maintain a healthy lifestyle. Participants will provide a yes/no response to each question and describe what they know about each topic. Changes in knowledge will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up.

Self-efficacy for behavior change will be assessed using five statements addressing participants' perceived ability to independently maintain a healthy lifestyle, establish goals, develop action plans to achieve healthy lifestyle goals, develop coping strategies to overcome barriers to maintaining a healthy lifestyle, and self-monitor and record their lifestyle behaviors. Each statement will be rated on a five-point Likert scale ranging from "strongly agree" to "strongly disagree." Changes in self-efficacy will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up.